Events

Device Recall Restoration Modular Hip System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52713
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2163-2009
  • 사례 시작날짜
    2009-06-26
  • 사례 출판 날짜
    2009-09-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83789
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 원인
    The raw material used in the production of the unipolar adaptor sleeve and the restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. as a precaution and due to the potential impact on the mechanical properties of the products, st.
  • 조치
    Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.

Device

Device Recall Restoration Modular Hip System
  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 627601-027; REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081901 26-Feb-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069602 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069603 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29081903 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29069601 02-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29299601 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014 REST MOD PROX CONE BODY 27mm +0mm (STD) 29448101 30-Mar-2014
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution
  • 제품 설명
    Restoration Modular Hip System; Proximal Cone Body; || 27 mm +0 mm (STD); || Not for use with + 16 V40 femoral Head. For Cementless Use Only. || Stryker Orthopaedics. || Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA